Randomized, single blind, non-inferiority study on the speed of action of lysin ibuprofen suspension vsibuprofen suspension in the treatment of acute pain in children (SAPed).

Phase 1

• Conditions: Acute pain in pediatric age; MedDRA version: 21.0Level: HLTClassification code: 10068757Term: Musculoskeletal and connective tissue pain and discomfort Class: 10028395; Therapeutic area: Not possible to specify

• Registration Number: CTIS2023-507510-27-00
• Lead Sponsor: Dicofarm S.p.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-12
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 192

Inclusion Criteria

1. Male and female pediatric subjects from =4 =12 years old.. 2. Subjects admitted to ER with acute pain as a primary symptom or an accompanying symptom (sore throat, headache, ear pain, toothache, post-traumatic musculoskeletal pain). 3. Pain intensity =4, assessed with validated age-related scale of 10 points. 4. Written informed consent provided by parents/tutor, willing and able to understand the purpose of the study, including possible risks and side effects, and willing and able to comply, on their behalf and of the minor, with the study requirements. 5. Willing and able to give additional written informed consent by itself, in case of children and adolescents, in addition to parents/tutor. 6. Willing and able, in case of children and adolescents, to comply with the study requirements on their behalf.

Exclusion Criteria

1. Subjects with hypersensitivity to ibuprofen, or to one of the components of IMP, or any other NSAID. 2. Chicken pox. 3. Dehydration. 4. Gastroenteritis. 5. Renal failure. 6. Thrombocytopenia, coagulopathies, and haemorrhagic diathesis. 7. A history of gastrointestinal bleeding or perforation related to previous drug treatments non-steroidal anti-inflammatory drugs (NSAIDs). 8. Peptic ulcer, active or recurrent gastrointestinal bleeding (two or more separate episodes occurring on ulceration or haemorrhage). 9. Severe heart failure (NYHA: class IV). 10. Severe liver failure. 11. Patients with hereditary fructose intolerance. 12. Wheat allergy. 13. Head and abdominal trauma. 14. The analgesic pain/ anti-inflammatory has already been administered at home (paracetamol in the previous 4 hours or ibuprofen in the previous 6 hours). 15. Subjects affected by delayed psychomotor development. 16. Vomiting after drug administration (drop out). 17. Participation in any other clinical study within the 3 months prior to the screening. 18. Pregnancy.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Evaluation of non-inferiority in the speed of action of lysin ibuprofen suspension versus ibuprofen suspension in the treatment of acute pain in children.;Secondary Objective: 1. Evaluation of the efficacy of lysin ibuprofen suspension versus ibuprofen suspension on the treatment of acute pain in children. 2. Evaluation of eventual superiority of lysin ibuprofen suspension versus ibuprofen suspension on the treatment of acute pain in children. 3. Evaluation of safety of lysin ibuprofen versus ibuprofen on the treatment of acute pain in children.;Primary end point(s): Non inferiority of speed of action of lysin ibuprofen suspension on pain intensity measured by validated agerelated scale (Wong-Baker Faces Pain scale and Numerical Rating Scale). The reduction of pain (abbreviated PAR, from pain relief) will be assessed at different time points on the difference in the values of the pain scales used. The main assessment is at five minutes timepoint.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):1. Evaluation of PAR general score after 10 , 20 and 30 minutes. 2. Evaluation of AEs/SAEs.